ESOQ New Product Business Quality Team Lead

Pfizer • Collegeville, PA

2d • Hybrid

About The Position

Use Your Power for Purpose Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your role is crucial. Your contributions directly impact patients, ensuring the highest standards of quality and safety. Join us in our mission to make a difference in patients' lives through dedication and excellence in every aspect of our work. What You Will Achieve Actively contributes as part of the ESOQ T3 structure by holding Quality responsibility for the selection, qualification, and onboarding of new partners/contractors into the External Supply network. In addition, the role has a responsibility to ensure co-development initiatives and new product launches are supported ensuring commercial readiness of both contractor(s) and product(s). The role is a highly empowered position, with the incumbent having maturity in operating in a risk-based virtual environment while ensuring compliance with cGMPs. This position reports to the ESOQ Quality Compliance and Business Excellence Team Lead. How You Will Achieve It Activities include but are not limited to the following: Provides strategic direction to a team of quality professionals across global locations, ensuring appropriate resources are in place and effectively organized to support all the stages related to contractor selections and on-boarding. Supports colleague development and performs talent assessments. Ensures an effective process for qualification and onboarding of new partners/contractors that includes; Execution of contractor selection audits, Negotiation of initial quality agreements (where relevant), Qualification of the new partners/contractors, Onboarding to the External Quality Operations Teams. Support of co-development initiatives and new product launches ensuring commercial readiness of both contractor(s) and product(s) Support technology transfers between two third parties or a third party and Pfizer site. Provides Quality support to PGS site divestiture teams and BDQ to ensure appropriate integration of the divested site into the External Supply network. Ensures an effective framework is in place to support the contractor selection process, identification and tracking of identified risks and appropriate management awareness and relevant leadership reviews. Is the quality representative at the Product Sourcing and ES sourcing council meetings. Participates or ensures team represented at T5/4 ES sourcing meetings. Effectively presents business issues across department or business line. Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities. Demonstrates confidence and maturity in operating within a risk-based environment and in compliance with current Good Manufacturing Practices. Develops and leverages resources to implement innovative ideas/processes/ products across business lines or sub-functions. Support ESOQ leadership on other tasks as required.

Requirements

• Bachelor’s degree (BA/BS) in Science, Engineering, Pharmacy, or a related technical discipline and minimum 8 years’ experience in pharmaceutical or medical device quality assurance roles.
• MBA/MS with at least 7 years of experience or PhD with at least 5 years of experience
• Deep expertise in GMP regulations, audit and inspection management, and leading quality systems.
• Experience with external suppliers/contractors and complex quality/compliance activities.
• Advanced proficiency in digital quality management systems and enterprise platforms (e.g., SAP, eQMS, Trackwise, Vault, Documentum).
• Demonstrated experience in continuous improvement methodologies (DMAIC, Six Sigma, Lean Belt trained preferred).
• Strong technical writing, verbal, and presentation skills.
• Proven leadership and facilitation skills, with the ability to influence and collaborate across all levels of the organization.
• Self-motivator with strong organizing, planning, and prioritization skills.
• Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and industry quality assurance practices.

Nice To Haves

• Experience in aseptic manufacturing and other pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Packaging, Development) and GDP requirements.
• Knowledge of main regulatory directives and guidelines (dossier structure, variation guideline).
• Knowledge of IMEx and OPEX.
• Method 1 certified and Method 2 or Lean Belt trained.
• Demonstrated breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of colleagues to achieve meaningful outcomes and create business impact.

Responsibilities

• Actively contributes as part of the ESOQ T3 structure by holding Quality responsibility for the selection, qualification, and onboarding of new partners/contractors into the External Supply network.
• Ensure co-development initiatives and new product launches are supported ensuring commercial readiness of both contractor(s) and product(s).
• Provides strategic direction to a team of quality professionals across global locations, ensuring appropriate resources are in place and effectively organized to support all the stages related to contractor selections and on-boarding.
• Supports colleague development and performs talent assessments.
• Ensures an effective process for qualification and onboarding of new partners/contractors
• Support of co-development initiatives and new product launches ensuring commercial readiness of both contractor(s) and product(s)
• Support technology transfers between two third parties or a third party and Pfizer site.
• Provides Quality support to PGS site divestiture teams and BDQ to ensure appropriate integration of the divested site into the External Supply network.
• Ensures an effective framework is in place to support the contractor selection process, identification and tracking of identified risks and appropriate management awareness and relevant leadership reviews.
• Is the quality representative at the Product Sourcing and ES sourcing council meetings.
• Participates or ensures team represented at T5/4 ES sourcing meetings.
• Effectively presents business issues across department or business line.
• Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities.
• Demonstrates confidence and maturity in operating within a risk-based environment and in compliance with current Good Manufacturing Practices.
• Develops and leverages resources to implement innovative ideas/processes/ products across business lines or sub-functions.
• Support ESOQ leadership on other tasks as required.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees